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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Value:
352.6 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalation is a likely route for exposure to the substance in regular use. According to ECHA guidance document the oral NOAEL (200 mg/kg bw/d, derived from the oral OECD407 study) is converted to an inhalatory NOAEC Worker as follows: 200 mg/kg bw /d / 0.38 m3/kg/d * 6.7 m3/10m3 * 100/100 = 352.6 mg/m3, whereas the first factor accounts for different respiratory volume from rats to humans, the second factor considers light weight activity respiratory volume increase by workers and the third factor takes account of an anticipated absorption via inhalative route compared to oral route (i.e. 100% for oral absorption, and 100% for inhalation).
AF for dose response relationship:
1
Justification:
NOAEC is used as the starting point
AF for differences in duration of exposure:
6
Justification:
based on the subacute study
AF for interspecies differences (allometric scaling):
1
Justification:
allometric scaling is not applied for the derivation of inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
no other substance-specific data are available.
AF for intraspecies differences:
5
Justification:
default factor for workers
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used .
AF for remaining uncertainties:
1
Justification:
no other uncertainties needed to be considered.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.67 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
As there is no direct information regarding dermal route for the substance, a worst case scenario is assumed in which the absorption rate via dermal route is considered to be same as oral route (both 100% as worst case). Thus, the NOAEL from the OECD 407 study being 200 mg/kg bw/d is used for the dermal route accordingly.
AF for dose response relationship:
1
Justification:
NOAEL is used as the starting point
AF for differences in duration of exposure:
6
Justification:
based on the subacute study
AF for interspecies differences (allometric scaling):
4
Justification:
rats are used
AF for other interspecies differences:
2.5
Justification:
no other substance-specific effects are available
AF for intraspecies differences:
5
Justification:
default factor for workers
AF for the quality of the whole database:
1
Justification:
Available data fulfill the scientific requirements
AF for remaining uncertainties:
1
Justification:
no other uncertainties need to be considered.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

There is no toxicity data available concerning the test substance on humans.

In a sub-acute toxicity study, the test article was administered daily by oral gavage to SPF-bred Wistar rats of both sexes at dose levels of 0, 50, 200 and 1000 mg/kg body weight/day for a period of 28 days. No treatment-related effects were noted on any parameter observed during the study, except of microscopic effects to kidneys (hyaline droplets), considered being treatment related. 200 mg/kg body weight/day of the test item was established as the no-observed-adverse-effect-level (NOAEL).

FAT41024 is expected to be absorbed in human via different routes - oral, dermal and inhalation route due to the physico-chemical properties (i.e., molecular weight approx.. 550 Dalton, low water solubility, mean particle size greater than 10 µm, high Log Pow).

As there is no direct information for the dermal route for the substance, except from acute toxicity studies, a worst case scenario is assumed in which the absorption rate via dermal route is considered to be same as oral route, and for both routes assumed to be 100% as worst case. Therefore, NOAELcorr for the dermal route is still 200 mg/kg bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalation NOAECworker of 352.6 mg/m³ (0.38 m³/kg in case of 8 h exposure/d for worker), consideration of light work activity by a factor of 6.7 m³ air inhaled divided by 10 m³ air and a default factor of 1 was assumed in the case of oral-to-inhalation extrapolation (i.e. 100% for oral absorption, and 100% for inhalation).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.16 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Value:
174 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalation is a likely route for exposure to the substance in regular use. According to ECHA guidance document the oral NOAEL (200 mg/kg bw/d, derived from the OECD 407 study) is converted to an inhalatory NOAEC General Population as follows: 200 mg/kg bw /d / 1.15 m3/kg/d * 100/100 = 174 mg/m3, whereas the first factor accounts for different respiratory volume from rats to humans and the second factor considers an anticipated absorption via inhalative route compared to oral route (i.e. 100% for oral absorption, and 100% for inhalation).
AF for dose response relationship:
1
Justification:
NOAEC is used as the starting point
AF for differences in duration of exposure:
6
Justification:
based on the sub-acute study
AF for interspecies differences (allometric scaling):
1
Justification:
allometric scaling is not applied for derivation of inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
no other substance-specific effects are available
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
available data fulfill the scientific requirments
AF for remaining uncertainties:
1
Justification:
no other uncertainties needed to be considered
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
A worst case scenario is assumed in which the absorption rate from dermal route is considered to be same as oral route, and for both routes assumed to be 100%.
AF for dose response relationship:
1
Justification:
NOAEL is used as starting point
AF for differences in duration of exposure:
6
Justification:
based on the subacute study
AF for interspecies differences (allometric scaling):
4
Justification:
rats are used
AF for other interspecies differences:
2.5
Justification:
no other substance-specific data are available
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
available data fulfill the scientific requirements
AF for remaining uncertainties:
1
Justification:
no other uncertainties need to be considered
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
none applied
AF for dose response relationship:
1
Justification:
NOAEL is used as the starting point
AF for differences in duration of exposure:
6
Justification:
based on the sub-acute study
AF for interspecies differences (allometric scaling):
4
Justification:
rats are used
AF for other interspecies differences:
2.5
Justification:
no other substance-specific effects are available
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
available data fulfill the scientific requirements
AF for remaining uncertainties:
1
Justification:
no other uncertainties need to be considered.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

There is no toxicity data available concerning the test substance on humans.

In a sub-acute toxicity study, the test article was administered daily by oral gavage to SPF-bred Wistar rats of both sexes at dose levels of 0, 50, 200 and 1000 mg/kg body weight/day for a period of 28 days. No treatment-related effects were noted on any parameter observed during the study, except of microscopic effects to kidneys (hyaline droplets), considered being treatment related. 200 mg/kg body weight/day of the test item was established as the no-observed-adverse-effect-level (NOAEL).

FAT41024 is expected to be absorbed in human via different routes - oral, dermal and inhalation route due to the physico-chemical properties (i.e., molecular weight approx.. 550 Dalton, low water solubility, mean particle size greater than 10 µm, high Log Pow).

As there is no direct information of dermal route for substance, a worst case scenario is assumed in which the absorption rate via dermal route is considered to be same as oral route, and for both routes assumed to be 100%. Therefore, NOAELcorr for the dermal route is still 200 mg/kg bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalation NOAECgeneral population of 174 mg/m³ (1.15 m³/kg in case of 24 h exposure/d for general population), and a default factor of 1 was assumed in the case of oral-to-inhalation extrapolation (i.e. 100% for oral absorption, and 100% for inhalation).